Articles and Blogs

On April 19, 2016, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) reached a settlement in the amount of $755,000 with a North Carolina orthopedic clinic (“Clinic”) for failing to execute a business associate agreement with a third-party vendor. This is OCR’s second settlement this year related to business... READ MORE

On January 20, 2015, the Food and Drug Administration (the “FDA” or “Agency”) published two draft guidance documents designed to fulfill promises it made in the multi-agency Food and Drug Administration Safety and Innovation Act (“FDASIA”) Health IT report. The first draft guidance is intended to promote the innovation of general wellness devices and... READ MORE

In November 2014, the ECRI Institute¹ issued a report discussing issues of patient safety and adverse events linked to health information technology (“IT”) products. The report comes in the form of an annual list of top ten health technology safety hazards. According to the ECRI Institute, although many facets of health IT have a... READ MORE

Executive Summary The Office of Federal Contract Compliance Programs (OFCCP) recently issued an administrative directive designed to clarify its position as to when health care providers are considered federal contractors or subcontractors subject to affirmative action obligations. The directive, which does not have the force of law, sets forth OFCCP’s own opinions and provides... READ MORE